OPUS MAGNUM PI KNOTLESS FIXATION DEVICE

Fastener, Fixation, Nondegradable, Soft Tissue

ARTHROCARE CORP.

The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Opus Magnum Pi Knotless Fixation Device.

Pre-market Notification Details

Device IDK070227
510k NumberK070227
Device Name:OPUS MAGNUM PI KNOTLESS FIXATION DEVICE
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ARTHROCARE CORP. 15285 ALTON PARKWAY SUITE 200 Irvine,  CA  92618
ContactLaura N Kasperowicz
CorrespondentLaura N Kasperowicz
ARTHROCARE CORP. 15285 ALTON PARKWAY SUITE 200 Irvine,  CA  92618
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-24
Decision Date2007-04-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817470005691 K070227 000
00817470005684 K070227 000
00817470005677 K070227 000
00817470005660 K070227 000
00817470005653 K070227 000
00817470005165 K070227 000

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